Mar 2013 - May 2014, Director of Process Validation, (EngiSystems)Alcon Manufacturing, Houston, TexasProject Manager, Maximo RemediationProvided leadership within the core team to maintain the vision and strategy established by Alcon and EngiSystems upper management to execute the following:Review CAPA and provide Gap assessment for MAXIMO Preventive Maintenance program’s state of compliance per 21 CFR part 11.Deploy team with clear objectives and empower team leaders to act with accountability.Execute plan by developing operational SOP’s, work flows, and job aids.Implementation: Work orders, facility drawings, job plans and PM’s are now in a secured qualified Document Controlled Management database oppose to the previous paper based system. Qualified equipment have standardized nomenclature for ease of traceability of location.

Aug 2009 – Oct 2009, FDA Remediation Project, Arkray, Group, Kyoto, JapanI was part of a team that was involved with FDA remediation. My role was statistical techniques using 21 CFR part 820.250, ISO 13485, and ISO 2859-1. Creating a Quality Engineering team to exercise quality approach within the QE team which included representatives from the following areas; CAPA, Non-Conformance, Validation, System Analysis, & Supplier control.

Oct 2007 – Dec 2008, Principal Validation Consultant, Boston Scientific Neuromodulation, Valencia CAImplemented and performed Attribute & Variable Test Method validation using Boston Scientific Corporation guidelines at the Valencia facility. Was appointed “approved signature authority” for the Director of Validation for the review and approval of approximately 110 validation protocols and reports. Was part of the Sylmar/Valencia "Phase I Move" validation. Was a team member in the FDA site approval for the Building 55B, Valencia Facility. Was the liaison for the Validation Project Manager in assisting validation activities with other validation consulting agencies and Boston Scientific employees. Streamlined new Installation, Operational and Process Validation protocols and reports. Was responsible for the process validation of the SCS II Implantable Pulse Generator. Worked on Failure Modes Effect Analysis, and Master Validation Plans/Reports. Performed and executed to include but not limited to the “Precision Automated Laser System, Laser welding, and vacuum bake” which was identified by the FDA as a critical process. Assisted in training personnel with Minitab version 15, to accomplish statistical data in the validation reports. Attended “Effective Business Writing” and “Process Validation” seminar. Was a volunteer for the "Make a Difference Day 2008" in Valencia, CA.

Apr 2006 – Jun 2006, Validation Consultant, Chesapeake Biological Laboratories, Contract Manufacturer, Baltimore, MdWrite Periodic Review of critical equipments throughout the facility. Write IOQ protocols for Terminal Sterilizer, Refrigerators, and the Compressed Air Systems. Identified deviations, CAPAs, Change Control, calibration, for the equipments that were scoped out on the assignment. Write addendum to the existing Compressed Air System. Worked with the drafting engineer to improve P&ID drawing for the compressed air system and the process air drop architecture drawing. Received Good Documentation Practices training.

HOFFMANN-LA ROCHE 9/2000 to 3/2002Project Lead• Awarded Process re-qualification on all utilities (clean steam, water systems etc.) in the facility $700,000• Temperature Mapping proposal for all warehouses in both Nutley and Totowa awarded• Installation and Operational Qualification of HVAC system• Gap analysis on existing critical utilities at both Nutley and Totowa facility

TARO PHARMACEUTICALS, Haifa Bay, Israel Project Lead 7/2000 to 9/2000• Establish a Validation Master Plan for the Haifa Bay, Israel facility• Performed audit at the facility

CHEMO DYNAMICS L.P.12/1999 to 5/2000Project Lead,• Managed and lead a team of 2 validation engineer in the completion of 2 reactor enclosures, with the following ancillary equipment:Vacuum Oven10 ton ChillerVacuum PumpCondenserTrane HVAC

ALMEDICA CORPORATION 12/1999 to 3/2000Project Lead• Successfully qualified a HVAC system for a Class 10,000• Submitted proposal and was awarded job for $35,000• Submitted 2nd proposal and was awarded job for 14 Carrier HVAC and one BAS system

BERLEX LABORATORIES 9/1999 to 12/1999 Project Lead• Managed and lead a team of 1 validation engineer and 1 validation specialist in completion of theQ.C. Laboratories• Project was over $50,000 and completed on schedule• Installation and Operational qualification was performed on the following pieces of equipment:Glassware DryerFume Hoods (12 units)Glassware Washer (2 units)Compressed Air Distribution o Electrical DistributionCompressed Lab Gases

PURDUE PHARMA L.P. PHARMACEUTICAL 7/199 to 12/1999 Project Lead• Managed and lead a team of 2 validation engineer and 3 validation specialist in completion of theGranulation Suite• Project was over $100,000 and completed on schedule and under budget by 10%• Installation and Operational qualification was performed on the following pieces of equipment: •York, 300 ton chillerTwo York, HVAC systemsBuilding automation systemsVac-u-max, vacuum transfer system o Niro, Fluid Bed Dryer